Clinical trial · Interventional
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma
NCT04458272CI-TRIAL-00106142active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| WHO Grade II Glioma | WHO Grade 2 Glioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DS-1001b | Drug | Safusidenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DS-1001b
- interventionNames
- Drug: DS-1001b
Primary outcomes (2)
- measure
- Overall response rate (ORR) assessed by Independent Efficacy Review Committee
- timeFrame
- Up to 24 months
- measure
- Number of participants with treatment-emergent adverse events (TEAEs) during the study
- timeFrame
- Up to 24 months
Secondary outcomes (11)
- measure
- Clinical benefit rate
- timeFrame
- Through the end of the study (up to approximately 6 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification. * Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory conducted during the screening period. * Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy. * Has at least 1 measurable and non-enhancing lesion. * Has an interval of at least 90 days from the latest surgery. * Has no sign of malignant transformation including the appearance of enhancing lesions and/or rapid growth of non-enhancing lesions. * Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1. Exclusion Criteria: * Has had a histopathological diagnosis of WHO grade III or IV glioma. * Has had a contrast enhancing lesion on brain MRI. * Has received a prior treatment with any mutant IDH1 inhibitor. * Has received other investigational products within 28 days before the start of the study drug treatment. * Has an active infection requiring systemic treatment. * Has multiple primary malignancies. * Has a history of clinically significant cardiac disease. * Is a pregnant or lactating woman.
References
Publications (2)
- DERIVEDArakawa Y, Saito R, Kanemura Y, Mishima K, Koriyama S, Narita Y, Kumabe T, Motomura K, Sugiyama K, Yamasaki F, Mukasa A, Kanamori M, Kuga D, Nagane M, Kakurai Y, Isobe K, Nakamura H. Phase II study of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naive isocitrate dehydrogenase 1-mutated WHO grade 2 gliomas. Neuro Oncol. 2026 Mar 1;28(3):717-727. doi: 10.1093/neuonc/noaf258. PMID 41206766
- DERIVEDNatsume A, Arakawa Y, Narita Y, Sugiyama K, Hata N, Muragaki Y, Shinojima N, Kumabe T, Saito R, Motomura K, Mineharu Y, Miyakita Y, Yamasaki F, Matsushita Y, Ichimura K, Ito K, Tachibana M, Kakurai Y, Okamoto N, Asahi T, Nishijima S, Yamaguchi T, Tsubouchi H, Nakamura H, Nishikawa R. The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas. Neuro Oncol. 2023 Feb 14;25(2):326-336. doi: 10.1093/neuonc/noac155. PMID 35722822